发布时间 : 星期日 文章New GMP ANVISA Regulation - RDC16 2013 - English Version(1)-对照译文更新完毕开始阅读
5.2.包装和标签粘贴控制及使用说明
5.2. Controls packaging, labeling and instructions for use
5.2.1.产品包装每个厂商应建立产品包装程序，以防止产品在处理、储存、搬运或销售过程中变质、损坏或污染。
5.2.1. Product packaging. Each manufacturer shall establish procedures for the packaging of goods so as to protect the product from deterioration, damage or contamination during processing steps, storage, handling and distribution.
5.2.2.产品标签粘贴 5.2.2. Product labeling
5.2.2.1.每个厂商应建立并维护产品标签粘贴程序，确保标签完整性，防止标签、使用说明、包装材料和识别标识的混淆。
5.2.2.1. Each manufacturer shall establish and maintain procedures to ensure the integrity and avoid accidental mixing of labels, instructions for use, packaging materials, and identification labels.
5.2.2.2.每个厂商应确保标签在设计、印刷、张贴（如适用）以及在产品处理、储存、搬运和使用过程中保持清晰可辨。
5.2.2.2. Each manufacturer shall ensure that the labels are designed, printed and, if applicable, applied to remain legible and attached to the product during processing steps, storage, handling and use.
5.2.2.3.标签和使用说明的检查在授权人员对标签和使用说明进行审查，确定其符合本技术规范相关信息之前不得投入使用。标签和使用说明的审批，包括日期、名称、负责人书面签名和电子版签名必须记录在产品的历史记录中。
5.2.2.3. Inspection of the labels and instructions for use. The labels and instructions for use shall not be released for use until an authorized person has reviewed its compliance regarding information contained therein. The approval, including date, name and physical or electronic signature of the person responsible, must be documented in the historical record of the product.
5.3.检查与测试
5.3. Inspection and testing
5.3.1.一般说明每个厂商应建立并维护检查、测试或其他验证方法的相关程序，确保其在整个制造过程中符合规定的要求。收到组成部分、制造材料时，以及在中间生产阶段的验收活动结果，以及成品的最终验收结果应进行记录，其中包括验收结果（接受或拒绝）。
5.3.1. General instructions. Each manufacturer shall establish and maintain procedures of inspection, testing or other means of verification to ensure compliance with the requirements specified in the full chain of manufacturing. The results of the activities of acceptance upon receipt of components and manufacturing materials as well as intermediate production stages and final acceptance of the finished product shall be documented, including its completion (acceptance or rejection).
5.3.2.每项活动的权限和职责由厂商确定。
5.3.2. The authority and responsibility for such activities shall be defined by the manufacturer.
5.3.3.收到的组成部分和制造材料，以及中间产品和退还的产品在检查证明其符合相关标准之前不得使用或进行处理。每个厂商应建立并维护相关程序，在检查、测试或其他检验完成并记录之前，对组成部分、制造材料、中间产品和退还产品进行保存。
5.3.3. Components and manufacturing materials received, as well as components, intermediate products, and returned products should not be used or processed until it is checked for conformance to requirements. Each manufacturer shall establish and maintain procedures for retaining components, manufacturing materials, intermediates, and products returned until the inspections, tests, or other established checks have been completed and documented.
5.3.4.部分或器械主文档完成之前，且记录档案和相关数据由指定人员审查之前不得对成品进行放行，确保所有验收标准都得到满足。产品的放行，包括日期和/或负责人签名电子版必须记录在案。
5.3.4. The finished products should not be freed until the activities specified in the PMR/DMR have been completed and until the documentation and associated data have been reviewed by a designated person to ensure that all acceptance criteria have been met. The release, including the date and or electronic signature of the person responsible, must be documented.
5.4.检验、测试和量具的要求
5.4. Inspection, test and measuring equipment.
5.4.1.每个厂商应确保所有测量和测试设备，包括机械设备、自动设备或电子设备适用于预期用途，且能够生成有效结果。每个厂商应建立并维护相关程序，确保对设备进行定期校准、检查和控制。对测量设备进行鉴定，确定设备的校准状态。 5.4.1. Each manufacturer shall ensure that all measuring and test equipment, including mechanical equipment, automated or electronic, is suitable for the purposes for which it is intended and be able to produce valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected and controlled. The measuring equipment shall be identified to enable the calibration status to be determined.
5.4.2.校准每个厂商应建立并维护校准程序，包括精度和准确度的特定指南和限制以及未达到指定精度和准确度时的纠正措施指示。
5.4.2. Calibration. Each manufacturer shall establish and maintain calibration procedures that include specific guidelines and limits of precision and accuracy, as well as prescriptions for corrective action when the limits of precision and accuracy are not achieved.
校准操作应由有相关教育和培训背景，并具备所需实践经验的人员来执行。
Calibration should be performed by personnel who have education, training, practice and experience needed.
5.4.3.校准标准每个厂商应建立并维护测量设备的校准标准，这些设备应该能够追溯国家标准或国家标准的相关官员。如果没有适用的标准，厂商应自行建立并维护适当标准。
5.4.3. Calibration standards. Each manufacturer shall establish and maintain calibration standards for measuring equipment that are traceable to national or international standards officers. If there is no applicable standard is available, the manufacturer shall establish and maintain its own pattern.
5.4.4.校准记录每个厂商应确保对校准测量结果获得日期、操作负责人和下一校准操作日期进行记录。校准记录由厂商负责，并确保使用设备或负责校准的人员能够获得相关记录。
5.4.4. Calibration records. Each manufacturer shall ensure that records are kept of the dates of calibration measurements obtained, the employee in charge of this task and the next date for this operation. Records shall be kept by the manufacturer and should be available for staff using this equipment and those responsible for the same calibration.
5.4.5.维护每个厂商应建立并维护相关记录，确保在测试设备、检查设备和测量设备使用过程中进行必要保护，以保持设备的精确度和适用性。
5.4.5. Maintenance. Each manufacturer shall establish and maintain procedures to ensure that the handling, preservation and care of test, inspection and measurement equipment to be made in order to preserve its accuracy and suitability.
5.4.6.设施每个厂商应保护相关设施以及检查设备、测试设备和测量设备，包括测试硬件和软件，避免设备调整过程中对校准状态产生破坏。
5.4.6. Facilities. Each manufacturer shall protect facilities and inspection, test and measurement equipment, including test hardware and software, from adjustments that would invalidate the calibration.
5.4.7.厂商应建立相关程序，在发现测试设备和测量设备不符合标准时，就这种情况对之前的测量结果的影响进行评估。评估的结果应进行记录。
5.4.7. The manufacturer shall establish procedures to assess the impact of the previous measuring results when non-compliances observed in test and measurement equipment. The result of the assessment should be documented. 5.5.确认
5.5. Validation
5.5.1.特殊流程必须根据已建立的条款进行确认。确认的结果，包括日期和负责人的鉴定批准应记录在案。
5.5.1. Special processes must be validated according to previously established protocols. The results of validations, including the date and identification of the person responsible for its approval, shall be recorded.
5.5.2.可能对产品质量或质量体系带来不利影响的分析方法、辅助系统支持过程或环境控制、自动信息系统和软件必须进行确认。
5.5.2. Analytical methods, auxiliary systems support process or environmental control, automated information systems and software that may adversely affect the quality of the product or the quality system must be validated.